Events

Recall of BRILLIANCE 40/64 SLICE CT SYSTEM - WORKSPACE PORTAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51622
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware that incorrect standardized uptake value ("suv") are displayed in two instances: 1. after loading pet data (with a slope value different than 1) into the quick review (qr) application from a remote device and 2. during the loading the above mentioned type of pet data into the ct viewer application from a remote device. after the images are loaded into the ct viewer the suv values are displayed correctly.

Device

BRILLIANCE 40/64 SLICE CT SYSTEM - WORKSPACE PORTAL
  • Model / Serial
    Model Catalog: 4550 110 02101 (Lot serial: N/A FOR ALL); Model Catalog: 4550 110 02101 (Lot serial: ); Model Catalog: 4598 001 31131 (Lot serial: )
  • Product Description
    BRILLIANCE 40/64 SLICE CT SYSTEM-WORKSPACE PORTAL
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC